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June 01, 2011

Last month, the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) sent a letter (and accompanying Appendix) to Commerce Secretary Gary Locke, expressing their appreciation and support for Secretary Locke's "continued leadership in promoting robust intellectual property standards and policies." BIO and PhRMA also commended the Department of Commerce and U.S. Patent and Trademark Office for their efforts in resisting proposals for new patent disclosure requirements concerning genetic resources and traditional knowledge that were advanced during meetings held at the World Intellectual Property Organization (WIPO) earlier this year.

The proposals made in WIPO stem from the Convention on Biological Diversity (CBD) and the Nagoya Protocol. The CBD is an international treaty that entered into force on December 29, 1993, and which has three main objectives: the conservation of biological diversity, the sustainable use of the components of biological diversity, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. The Nagoya Protocol -- more properly the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity -- is a supplementary agreement to the CBD, which has not yet entered into force (the agreement is open for signature by Parties to the CBD until February 1, 2012), and which has as its objective the fair and equitable sharing of benefits arising from the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity.

In the BIO-PhRMA letter, the industry groups praised the Department of Commerce and USPTO for "effectively resist[ing] demands from certain countries to commence negotiations on ill-advised and harmful changes to the global patent system relating to 'genetic resources' and 'traditional knowledge'" at the WIPO meetings. The groups contended that "[s]uch changes would undermine the ability of U.S.-based innovative companies to protect their inventions and their ability to thrive, create jobs and compete fairly in global markets." The proposed disclosure requirements would require patent applicants to disclose the source or origin of any genetic resources or traditional knowledge upon which an invention is based.

Although BIO and PhRMA indicated that they supported the principles embodied in the CBD and Nagoya Protocol, their letter states that "the proposals for new patent disclosure requirements concerning genetic resources and traditional knowledge being advanced in WIPO ignore these principles," and "have many practical and conceptual flaws." According to the letter, the proposals would "introduce uncertainties in the patent system that would undermine entire patent portfolios for companies that use natural materials, particularly for those in the life sciences." In addition, the letter argues that it will not be possible for applicants to knowingly comply with the proposed disclosure requirements. In the Appendix to the letter, the industry groups explain that "exhaustively determining the source or origin of a genetic resource -- which may include cell lines or other genetic resources that have been available on the open market for decades -- is a complex, costly, time consuming and ultimately uncertain exercise." The letter also notes that "no attempt has been made to show how the proposed disclosure requirements could actually remedy the concerns that motivate these proposals -- i.e., the unauthorized collection and use of genetic resources." The Appendix offers additional criticism of the proposed disclosure requirements, stating that "[n]o attempt is made to limit obligations to genetic resources actually governed by the CBD (i.e., samples of non-human materials that are collected by the patent applicant after the CBD entered into force and after its provisions are implemented in national law)," and adding that "the sanction demanded [under the proposal] -- denial or revocation of the patent -- is plainly excessive and inappropriate." Moreover, the groups note that the proposed disclosure requirements would not further the objectives of the CBD because "a disclosure requirement could cover only a tiny fraction of the activities that advocates say are occurring" (i.e., such a requirement would not address uses of genetic resources that do not lead to patents).

Instead of implementing the proposed disclosure requirements, the BIO-PhRMA letter encourages the international community to "identify mechanisms that would provide for meaningful monitoring of the collection and use of genetic resources as well as safeguards against illegal uses of such genetic resources," and points to examples of "constructive proposals" under consideration by WIPO, which include "a 'one-stop-shop' database to improve the quality of patent examination, model material transfer agreements that contain enforceable cross-border provisions and stating that guidelines for contractual practices relating to managing intellectual property in ABS agreements."

I'm all for increased efficiency and cross-border collaboration and cooperation. One difficulty, however, is that some of the attempts at harmonization in the U.S. create provisions that potentially conflict with long-standing US law and/or tradition. The House version of the current patent reform bill presents just one example of this. Retention of national sovereignty is a big issue in harmonization, and it still hasn't been adequately addressed, in my opinion.http://www.aminn.org/patent-reform-act-2011-s23